Subsequent entry biologics (SEBs) may soon be a reality in Canadian nephrology practice. Along with opportunities to reduce healthcare costs, these agents pose unique challenges to successful implementation. Understanding the experiences around the globe in both regulatory affairs and implementation will be a valuable guide for Canadian clinicians. This review should assist clinicians and policymakers to navigate this complex subject and to make informed decisions in the best interest of their patients [1].
There exists a common and robust approach in the G20 countries for approval and regulation of SEBs. Although by definition these agents do not have advantages (other than cost) or disadvantages compared to the originator biological, there are potential concerns and economic uncertainties regarding their implementation. Where SEBs are on the market, their market share has been variable and modest.
Issues include the actual compared to perceived price differences in a competitive marketplace. A phamacoeconomic analysis incorporating the originator price response to a new SEB should be conducted. Drug safety (potential immunogenicity, inadvertent switching) and efficacy (actual similarity as seen in clinical trials) should remain paramount in any review. Additionally, automatic substitution and therapeutic interchangeability regarding these products will need to be addressed to ensure safe use.
Once approved, the SEB is not compared to the originator biological again and both products may ‘drift’ apart over time with various manufacturing changes. As a result, these products should not be considered interchangeable or substitutable now or into the future. Likewise, clinicians should adhere to the indications granted by Health Canada and not extrapolate use beyond these. Regulators only grant extensions of indications where they deem it is safe and reasonable to do so. Finally, the issue of the International Nonproprietary Name (INN) should be clearly understood so as to avoid inadvertent switching between products.
The nephrology community will have to work with patients, payers and regulatory bodies to ensure safe and effective use of SEBs. Cost savings can likely be achieved but these agents should only be used after fully understanding their unique challenges. Only through good pharmacovigilance will healthcare providers and patients become better informed.
This review focused on the global landscape of regulatory responses to SEBs and the most likely entrants to Canadian nephrology practice over the next five years. Erythropoietin alfa will likely have at least one SEB, rituximab may have an SEB by the end of the decade while darbepoetin and alteplase will not.
SEB use will be influenced by many factors as well as by third-party payers, patient advocacy groups, buying groups and clinician bias. Education provided to all these groups regarding SEBs should be unbiased and free from industry influence to ensure appropriate use of SEBs.
Conflict of interest
The authors of the research paper [1] declared that there were no conflicts of interest.
Abstracted by Daniel J Martinusen, BSc (Pharm), ACPR, PharmD, British Columbia Provincial Renal Agency & Royal Jubilee Hospital, Island Health Authority, Vancouver, Canada.
Editor’s comment
Readers interested to learn more about subsequent entry biologics in Canada are invited to visit www.gabi-journal.net to view the following manuscripts published in GaBI Journal:
Subsequent entry biologics (biosimilars) in Canada: approaches to interchangeability and the extrapolation of indications and uses
Readers interested in contributing a research or perspective paper to GaBI Journal – an independent, peer reviewed academic journal platform – please send us your submission here.
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Reference
1. DJ Martinusen, C Lo, JG Marin, NW Tsao, M Leung. Potential impact of subsequent entry biologics in nephrology practice in Canada. Can J Kidney Health Dis. 2014;1:32.
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